title: A phase 3, randomized, double-blind comparison of analgesic efficacy and tolerability of Q8003 vs oxycodone or morphine for moderate-to-severe postoperative pain following bunionectomy surgery.
abstract: OBJECTIVE
  Compare the efficacy and tolerability of the dual-opioid, Q8003(®) (morphine/oxycodone combination) 12 mg/8 mg to morphine 12 mg or oxycodone 8 mg in subjects following bunionectomy surgery.
  
  
  METHODS
  This was a randomized, double-blind study.
  
  
  METHODS
  Hospitalized patients.
  
  
  METHODS
  Healthy men or women aged ≥18 years with moderate or severe pain (score ≥2 on a 4-point Likert scale) and ≥4 on the 11-point numerical pain rating scale following surgery.
  
  
  METHODS
  Study medication was initiated after surgery and was given for 48 hours.
  
  
  RESULTS
  The primary efficacy variable was mean sum of the pain intensity difference (SPID) scores from the postsurgical baseline.
  
  
  RESULTS
  Five hundred twenty-two subjects were randomized; 31 (5.9%) discontinued, including 19 (3.6%) for adverse events. The mean total morphine equivalent dose (MED) was 182.7 mg from Q8003 12 mg/8 mg, 92.4 mg for morphine 12 mg, and 92.1 mg for oxycodone 8 mg. SPID from baseline over 24 hours and SPID from baseline over 48 hours were significantly (P < 0.02) higher for Q8003 12 mg/8 mg vs morphine 12 mg or oxycodone 8 mg. Significantly (P < 0.015) fewer subjects in the Q8003 group required ibuprofen rescue medication, used lower doses of rescue medication, and had a longer median time to first use of rescue medication. Oxygen desaturation <90% occurred in 5.3% with Q8003, 2.8% with morphine 12 mg, and 2.3% with oxycodone 8 mg, and the cumulative median dose at first desaturation was twofold greater with Q8003.
  
  
  CONCLUSIONS
  Q8003 provided superior efficacy to its individual components at twice the MED with only a modest increase in the incidence of adverse events.
authors.affiliation: QRxPharma Inc., Bedminster, New Jersey 07921, USA. patricia.richards@qrxpharma.com
authors.forename: Patricia
authors.initials: P
authors.lastname: Richards
authors.forename: Dennis
authors.initials: D
authors.lastname: Riff
authors.forename: Robin
authors.initials: R
authors.lastname: Kelen
authors.forename: Warren
authors.initials: W
authors.lastname: Stern
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D023381:Endpoint Determination; D005006:Ethnicity; D005260:Female; D006215:Hallux Valgus / Q000601:surgery*; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000009:adverse effects / Q000627:therapeutic use*; D010098:Oxycodone / Q000009:adverse effects / Q000627:therapeutic use*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; C576454:MoxDuo; D009020:Morphine; D010098:Oxycodone; D007052:Ibuprofen
keywords: Acute Pain; Morphine; Opioid; Opioid-Related Side Effects; Oxycodone; Postoperative Pain; Q8003